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WOCKPHARMANSEWockhardt Limited· Pharmaceuticals & BiotechnologyHighPositive
Announced Thu, 25 Sept, 2025 · 16:16 IST

Pursuant to Regulation 30 of Listing Regulations, please find enclosed Press Release Prestigious Medical and Public Health Journal THE LANCET Regional Health Publishes Pivotal Phase 3 Clinical Study on Miqnaf® (Nafithromycin) A Landmark for India s Antibiotic Innovation .

Regulatory product approvalBusiness Updates View source PDFExplain this filing

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On the reaction day the stock moved 5.6 pts less than Nifty Smallcap 250 and 5.5 pts less than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

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AI summary

Wockhardt announced that The Lancet Regional Health Southeast Asia, a peer-reviewed medical journal, has published the full Phase 3 clinical study results of Miqnaf® (nafithromycin), a novel antibiotic for treating community-acquired bacterial pneumonia (CABP). This is the first-ever publication in a Lancet journal for a novel drug discovered and developed in India. The Phase 3 trial, conducted in nearly 500 patients, showed Miqnaf® was non-inferior to moxifloxacin, with over 90% of patients showing clinical improvement within 3-4 days. Miqnaf® is the first new macrolide antibiotic in over 30 years, offers a once-daily, three-day oral regimen, and already holds Qualified Infectious Disease Product (QIDP) designation from the US FDA.

Likely market impact

The high-profile Lancet publication strengthens global scientific credibility for Miqnaf® and Wockhardt's antibiotic pipeline, potentially supporting future US FDA approval efforts and international market expansion. This is a positive reputational milestone, though it does not directly translate to immediate revenue impact. Wockhardt derives ~77% of revenues from international businesses, so global recognition could support long-term growth in its pharma segment.